No need for jab to be approved by WHO, says FDA

No need for jab to be approved by WHO, says FDA

The Food and Drug Administration (FDA) has confirmed that each country has the right to register Covid-19 vaccines that will be used by their people without relying on a vaccine list approved by World Health Organisation (WHO).

Secretary-General of the FDA Paisarn Dunkum said Covid-19 vaccines approved according to the WHO Emergency Use Listing Procedure (EUL) are for use under the Covax initiative. The procedure can also be used as a reference when considering Covid-19 vaccine registration in countries with an incomplete vaccine regulatory system, he said.

The doctor insisted it did not mean that vaccines outside WHO's list were substandard, saying vaccines from Pfizer, Moderna, AstraZeneca and Johnson & Johnson had all been registered in countries such as the UK, the US and some European countries before they were approved by WHO EUL.

Thailand had a vaccine regulatory system approved by WHO's Prequalification Programme and was a member of the Pharmaceutical Inspection Co-operation Scheme, the doctor said. The country was therefore able to register Covid-19 vaccines by itself, he said, adding Thailand had registered AstraZeneca's Covid-19 vaccine before it was approved by WHO EUL.

CoronaVac, Sinovac's Covid-19 vaccine, has been approved by over 45 countries worldwide. It passes WHO's efficacy threshold with over 50% efficacy against infection, 100% efficacy against preventing fatalities and 77.9% efficacy to prevent hospitalisation from severe symptoms.

In Chile, CoronaVac is 67% effective in preventing symptomatic infections, 85% in preventing hospitalisation, 89% in preventing the infected from entering ICUs and 80% in preventing death, according to WHO.

Covid-19 vaccines approved by the FDA were safe and effective against Covid-19, he said.

The administration has approved three Covid-19 vaccines including AstraZeneca, Sinovac and Johnson & Johnson vaccines. Moderna's vaccine is under review, according to the FDA chief.


Do you like the content of this article?
COMMENT (37)

State agencies pressured to upgrade

Thailand needs to accelerate digitalisation among its state agencies to facilitate ease of doing business, while workers need better technical skills to improve the country's competitiveness on the global stage, according to the state planning unit chief.

11:00

New clinic for trans healthcare

Chulalongkorn Memorial Hospital is trumpeting the work being done at its new Gender Health Clinic (GHC), one of the first to focus specifically on catering to the needs of the transgender community.

10:00

Hong Kong pro-democracy media executives appear in court

HONG KONG: Two executives from Hong Kong's pro-democracy Apple Daily appeared in court on Saturday charged with collusion after authorities deployed a sweeping security law to target the newspaper, a scathing critic of Beijing.

09:45